Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and...

FDA Recall #D-0120-2025 — Class II — November 18, 2024

Recall #D-0120-2025 Date: November 18, 2024 Classification: Class II Status: Ongoing

Product Description

Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Reason for Recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Recalling Firm

Viatris Inc — Canonsburg, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

9,828 bottles

Distribution

Nationwide within the United States and Puerto Rico

Code Information

Lot #: a) 8177720, Exp. Date Jun 2025; b) 3200218, Exp. Date Jun 2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated